Disinfection process sampling device

ABSTRACT

Various examples disclosed relate to a device for use in a disinfection process. The device can include, for example, a sampling assembly capable of a first position and a second position, wherein the sampling assembly is configured to be used inside a sterilization system. The sampling assembly can include a top portion, a bottom portion, at least one seal therebetween such that the top portion and the bottom portion form an airtight compartment when in the first position, a central pin running through the top portion and bottom portion, and an actuator configured to move the sampling assembly between the first position and the second position along the central pin during a portion of the disinfection process, such that the sampling assembly can collect a sample of atmosphere within the disinfection system.

PRIORITY CLAIM

This application claims priority and benefit of U.S. Provisionalapplication with Ser. No. 63/024,305, filed May 13, 2020, entitledDISINFECTION PROCESS SAMPLING DEVICE, which is herein incorporated byreference in its entirety.

BACKGROUND

Sterilization and disinfection systems, for example those systems usedto sterilize medical equipment and devices, often are validated prior touse. Validation can, for example, ensure that the sterilization ordisinfection system is functioning properly and killing or disabling asufficient amount of microorganisms to sterilize the equipment beingtreated. In some cases, validation can include confirming the amount ortype of chemical composition inside a sterilization chamber ordisinfection environment.

In a sterilization or disinfection device, cycles can generally containa number of phases. For example, many sterilization or disinfectioncycles can include a conditioning phase, such as where a vacuum iscreated in the system, an injection phase where a sterilant ordisinfectant is inserted into the system, a sterilization ordisinfection phase where the products are sterilized or disinfected bythe sterilant or disinfectant, and a ventilation phase where thesterilant or disinfectant is vented out of the system. Due to thesevarious phases, the amount of microorganisms and the amount of sterilantor disinfectant in the system can significantly vary over the course ofthe system cycle.

Conventionally, a resistometer can be used to verify sterilization ordisinfection systems to expose biological or chemical indicators to theenvironment in the system and determine whether sufficient sterilizationor disinfection is occurring during the cycle. Where a resistometer isused, the biological or chemical indicators remain exposed to theatmosphere in the sterilization system throughout the duration of thesterilization or disinfection cycle, through all phases of the cycle.For this reason, verification of a sterilization or disinfection systemwith a resistometer cannot indicate at what point in the cyclesterilization or disinfection can occur, to what degree, or mapsterilization or disinfection to various phases of the system cycle.

SUMMARY OF THE DISCLOSURE

Disclosed herein is an apparatus and associated methods for analyzingthe environment of a sterilizing or disinfecting instrument, such asdetecting the number of microorganisms present with a biologicalindicator, or detecting the type or make-up of sterilant, disinfectant,or other chemicals present in the sterilizing or disinfectinginstrument. The sampling apparatus can alternatively be used formeasuring temperature, pressure, humidity, or other parameters during asterilization or disinfection process. The sampling apparatus canprovide a controlled environment to minimize the effect of otherpossible dynamic effects for better understanding of the sterilizationor disinfection process.

Verification of sterilization or disinfection systems or environmentscan allow users to ensure that the products they are sterilizing, ordisinfecting are, in fact, sterile or disinfected after running theproducts through a system cycle. Verification can, for example, beperformed with external sterilization or disinfection verificationtools, such as a resistometer that runs in parallel with a sterilizationsystem while cycling. In this case, the resistometers is hooked up tothe same sterilant/disinfectant, gas, vacuum, or other incoming sourcesas the system, and a sterilization or disinfection cycle is run on thesystem. The atmosphere in the resistometer theoretically reflects theatmosphere inside the system or environment.

Often, biological or chemical indicators are inserted into theresistometer. Biological indicators can be used in such an analysis. Ingeneral, biological indicators can be measured for a D-value indicatinghow long it takes to reduce a microorganism population by 90%, or thetime needed to 1-log reduction of microorganisms. Chemical indicators,by contrast, can indicate whether an amount of a particular chemical,such as a component of a sterilant, is present. Both biological andchemical indicators can be expensive.

In a resistometer validation method, the indicators can be exposed tothe external atmosphere throughout the duration of the sterilization ordisinfection cycle. The user can then remove the indicators from theresistometer after the cycle is complete, and determine whether theatmosphere in the resistometer validates the sterilizing or disinfectingsystem.

The system and methods disclosed herein are directed to a samplingassembly for verification of a sterilization or disinfection process andsystem that allows for temporal sampling throughout the cycle. Forexample, the sampling assembly can be opened to expose biological orchemical indicators to the atmosphere in the sterilization chamber ordisinfection environment, and subsequently closed while thesterilization or disinfection cycle is still running.

Additionally, the sampling assembly can reside in the sterilization ordisinfection chamber itself of the sterilization or disinfection system.For this reason, the sampling assembly does not collect samples inparallel, and instead can sample the atmosphere inside the sterilizationor disinfection system.

In an example, a device for use in a sterilization or disinfectionprocess can include a sampling assembly capable of a first position anda second position, wherein the sampling assembly is configured to beused inside a sterilization or disinfection system. The samplingassembly can include a top portion, a bottom portion, at least one sealtherebetween such that the top portion and the bottom portion form anairtight compartment when in the first position, a central pin runningthrough the top portion and bottom portion, and an actuator configuredto move the sampling assembly between the first position and the secondposition along the central pin during a portion of the sterilization ordisinfection process, such that the sampling assembly can collect asample of atmosphere within the sterilization or disinfection system.

In an example, a method of validating a sterilizing or disinfectingsystem can include situating a sampling assembly in a chamber of thesterilizing or disinfecting system, the sampling assembly comprising atop portion, a bottom portion, and at least one seal therebetween suchthat the top portion and the bottom portion form an airtightcompartment; running a sterilization or disinfection cycle on thesterilizing or disinfecting system; opening the sampling assembly duringa portion of the sterilization or disinfection cycle; collecting asample in the sampling assembly; and analyzing the sample.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, which are not necessarily drawn to scale, like numeralsmay describe similar components in different views. Like numerals havingdifferent letter suffixes may represent different instances of similarcomponents. The drawings illustrate generally, by way of example, butnot by way of limitation, various embodiments discussed in the presentdocument.

FIG. 1 is a schematic diagram of an example sterilization system.

FIG. 2A is an exploded view of a sampling assembly for verifying theenvironment in a sterilizing or disinfecting system.

FIGS. 2B-2C are perspective views of the sampling assembly from FIG. 2A,for verifying the environment in a sterilizing or disinfecting system.

FIGS. 3A-3B are perspective views of the sampling assembly, forverifying the environment in a sterilizing or disinfecting system, in anadditional example.

FIG. 4 is a graphical illustration of a cycle in a sterilizing ordisinfecting system.

FIG. 5 is a flowchart depicting a method of using a sampling assemblyfor verifying the environment in a sterilizing or disinfecting system.

DETAILED DESCRIPTION

The present disclosure describes, among other things, devices andmethods for validating a sterilization or disinfection system byinternally testing the sterilization or disinfection system. As usedherein, “disinfection,” “disinfecting,” and “disinfectant” can includemethods, devices, and compositions for reduction of microorganisms in anenvironment, such as by the process of cleaning something to destroy ordisable those microorganisms, which may include harmful pathogens intheir vegetative state and reducing their amount to a non-threateninglevel. As used herein, “sterilization,” “sterilizing,” and “sterilant”can include methods, devices, and compositions for killing orinactivating substantially all microorganisms from a product or surfaceeither in a vegetative or spore state. Sterilization can include, forexample, a 12-log reduction of microorganisms. Disinfection can includesterilization.

FIG. 1 is a schematic diagram of an example sterilizing system 100 inwhich a sampling assembly 200 can be used. In other examples, adisinfection system can be used. The example sterilizing system 100 caninclude, for example, sterilization chamber 110 with door 111, seal 112,atomizer inlet 113, vent 114, air filter 115, temperature sensor 116,and relative humidity sensor 117; vacuum hookup connection 120 with gasflow meters 122, vacuum control valve 123, chamber vacuum control valve124, vacuum pumps 127, filters 125, 126, 128, and muffler 129; atomizerassembly 130 with sterilant 131, chemical inlet 132, chemical pump 133,chemical flow meters 134, air inlet 135, pressure regulator 136, airfilter 137, air flow control 138, air valve 139, atomizer purge 140, andpressure transducers 141; in addition to controller 150 with userinterface 155 and sampling assembly 200.

The sterilization chamber 110 can include, for example, a chamber forinsertion of medical equipment or other items to be sterilized. Thesterilization chamber 110 can be of any appropriate size for the itemsto be sterilized. For example, in some examples, the sterilizationchamber 110 can be about 300 to about 500 L. In some examples, thesterilization chamber 110 can be about 2,000 to about 4,000 L. Thesterilization chamber 110 can be accessed by a user by, for example, thedoor 111. The door 111 can be, for example, on one side of thesterilization chamber 110, and the door 111 can be large enough to allowfor insertion of the items for sterilization. The door 111 can be, forexample, airtight so that a vacuum can be applied inside thesterilization chamber 110 for sterilization of the medical equipment orother items. In some examples, the door 111 can be shut with a seal 112in or around the door 111. In some cases, such as with a disinfectionsystem, a disinfection environment can be used instead of asterilization chamber.

The sterilization chamber 110 can have, in or on one or more sides, anatomizer inlet 113 and a vent 114. The atomizer inlet 113 can allow forinflux of a chemical composition, such as one or more sterilant ordisinfectant, into the sterilization chamber 110 to interact with andsterilize or disinfect the medical equipment or other items. Thesterilant or disinfectant can be, for example, atomized, vaporized, orin other gaseous form, as desired, for sterilization.

The vent 114 in the sterilization chamber 110 can allow for venting ofthe sterilization chamber as desired. Venting of the environment insidethe sterilization chamber can be performed, for example, to maintain aparticular pressure inside the chamber, or to alter the pressure insidethe chamber over time. An air filter 115, such as a HEPA air filter,can, for example, be in fluid communication with the vent 114, to allowgas or air to pass out of the sterilization chamber 110 and be filteredfor chemicals, as the gas leaves the sterilization chamber 110.

The sterilization chamber 110 can also include, for example, a number ofsensors, such as a temperature sensor 116, a relative humidity sensor117, combinations thereof, or other sensors such as pressure, optical,flow rate sensors, or combinations thereof. The sensors 116, 117, orother additional sensors, can, for example, be in communication with acontroller or processor, such as controller 150, to allow manipulationof the sterilization process in the sterilization chamber 110 based onparameters sensed, such as temperature or humidity.

The vacuum hookup connection 120 can connect the sterilization chamber110 to a vacuum source. The vacuum hookup connection 120 can include,for example, the gas flow meters 122, the vacuum control valve 123, thechamber vacuum control valve 124, the vacuum filters 125, 126, 128 thevacuum pumps 127, and the muffler 129.

The vacuum hookup connection 120 can allow for an airtight connectionbetween the sterilization chamber 110 and the vacuum system. The vacuumsystem can, for example, include one or more gas flow meters 122 tomonitor the flow of gas in and out of the sterilization chamber 110before, during, and after a sterilization cycle.

The valves 123, 124, can allow for specific control of the flow rate ofgas in the vacuum system, so as to create a specific pressure inside thesterilization chamber 110. The vacuum filters 125, 126, 128, also alongthe vacuum lines, can allow for cleaning of air being used in the vacuumsystem. The filters can include, for example, polypropylene filters,sodium bicarbonate filters, potassium permanganate filters, and othertypes of filters appropriate for a vacuum sterilization system.

The vacuum pumps 127 can, for example, create a vacuum along the vacuumsystem so as to induce a vacuum in the sterilization chamber 110. Themuffler 129 can, for example, minimize noise created by the vacuumsystem.

The atomizer assembly 130 can include, for example, a sterilant 131, achemical inlet 132, a chemical pump 133, chemical flow meters 134, anair inlet 135, a pressure regulator 136, an air filter 137, an air flowcontrol 138, an air valve 139, an atomizer purge 140, and one or morepressure transducers 141.

In system 100, a sterilant is atomized for the sterilization processinside the sterilization chamber 110. In some sterilization systems, asterilant is vaporized, or supplied as a liquid. In some sterilizationsystems, the sterilant is atomized or vaporized in a separate chamber,and then pumped or run into the sterilization chamber. The samplingassembly 200 can be used, for example, in any of these types ofsterilization systems.

In the example sterilization system 100 shown in FIG. 1, the sterilant131 is stored as fluid in bottles. In some examples, other containers,with various shapes or storage methods, could be used.

The sterilant 131 is connected to the chemical inlet 132 into theatomizer assembly 130, and the sterilant can be moved, for example, bythe chemical pump 133, and the rate of movement of the sterilant can bemonitored by the chemical flow meters 134.

At the air inlet 135 of the atomizer assembly 130, air (or other gas)can enter the atomizer assembly 130 for use in atomizing the sterilant.The pressure regulators 136 can monitor the pressure of the air in theatomizer assembly 130 to allow proper atomization of the sterilant. Oneor more air filters 137, air flow controls 138, and air valves 139, canbe used in manipulating the flow of air and sterilant to induceatomization of the sterilant in the sterilization chamber 110. Theatomizer purge 140 can allow for venting or dumping of excess air orsterilant depending on pressure feedback. The pressure transducers 141can, for example, monitor the pressure of sterilant as it is atomized.

In system 100, the controller 150 can be in communication with thevacuum system, atomizer assembly 130, and the sterilization chamber 110.The controller 150 can, for example, include a processor and memory thatcan received sensed data from the various sensors in the system, anddirect changes in the valves or air lines within the system. Thecontroller 150 can, for example, manipulate the pressure in thesterilization chamber created by the vacuum system, and the amount andrate of atomized sterilant entering the system.

The controller 150 can be, for example, connected to a user interface155, so as to communicate this information to the user. The userinterface can, for example, include a screen, or one or moreuser-actuated buttons or triggers to allow to user to read informationand alter the sterilization process as desired.

Sampling assembly 200 can be used inside the sterilization chamber 110of the system 100 to verify the sterilization processes of the system100. The sampling assembly 200 can be placed or located physicallyinside the sterilization chamber 110, either loose or mounted to theinside of the sterilization chamber 110. The sampling assembly 200 cancarry in it one or more indicators, such as biological indicators orchemical indicators, that can react with the atomized sterilant when asterilization cycle is run on the system 100. The sampling assembly 200is discussed in more detail with references to FIGS. 2A-2C and 3A-3Bbelow.

The sterilization system 100 discussed herein is one example of asterilizing or disinfecting system in which a sampling assembly, such asthe sampling assembly 200, can be used. In some examples, a differenttypes of disinfection or sterilization system can be used.

FIG. 2A is an exploded view of a sampling assembly 200 for verifying theenvironment in a sterilizing or disinfecting system. FIGS. 2B-2C areperspective views of the sampling assembly 200, for verifying theenvironment in a sterilizing or disinfecting system. FIG. 2B depicts thesampling assembly 200 in a closed position, while FIG. 2C depicts thesampling assembly 200 in an open position. FIGS. 2A-2C will be discussedtogether.

Assembly 200 can include, for example, chamber 205 with bottom portion210 and top portion 220. Bottom portion 210 can include, for example,tray 212, central opening 214, sealing groove 216, and fluid flow ports218, 219; top portion 220 with central opening 224, locking pin 225, andsealing ring 226; central pin 230; actuator 240; and base 250 withplatform 252 and handles 254.

Chamber 205 can be, for example, for holding indicators, such asbiological or chemical indicators, for validating sterilization in asterilization system. In some cases, chamber 205 can be adapted forcapturing a portion of the atmosphere inside a sterilization system, sothat the atmosphere can be tested. Chamber 205 can include, for example,a bottom portion 210 and a top portion 220 such that the chamber 205 canopen or close when inside a sterilization system for testing orvalidation of the sterilization process while the sterilization processis running.

The bottom portion 210 can include, for example, a tray 212 for holdingbiological or chemical indicators. The tray 212 can be shaped to hold inplace one or more indicators during a sterilization or disinfectionprocess. In some cases, the bottom portion 210 can further include arack configured for holding indicators.

The bottom portion 210 can additionally include one or more fluid flowports 218, 219. The fluid flow ports 218, 219 can be adapted for ventingthe sampling assembly 200. In some cases, one or more of the fluid flowports can be adapted for creating a vacuum in the sampling assembly 200.

The top portion 220 can act as a lid for the bottom portion 210,together creating a chamber 205 for sampling a sterilization ordisinfection atmosphere. The top portion 220 and the bottom portion 210can, for example, have the same diameter to allow sealing together intoone chamber 205.

The locking pin 225 can be located in the top portion 220 to allow forlocking of the chamber 205 when open, and prevents accidental closing ofthe top portion 220 onto the bottom portion 210. The locking pin 225 canbe, for example, a safety pin. The locking pin 225 can be, for example,a quick release pin to better access the load of the sampling assembly200.

The central pin 230 can run between the top portion 220 and the bottomportion 210, allowing the portions to stack on top of one another andseal to each other at the sealing groove 216. In some examples, thecentral pin 230 can have one or more ridges to prevent the top portion220 or the bottom portion 210 from unintentionally moving towards theother portion. For example, the central pin 230 can have an upper ridgefor preventing the top portion 220 from collapsing onto the bottomportion 210, except when desired. For example, the central pin 230 canhave a lower ridge for preventing the bottom portion 210 from movingupwards towards the top portion 220, except when desired.

The central opening 214 in the bottom portion 210 and the centralopening 224 in the top portion 220 can be aligned to each other, and canbe fitted to the central pin 230. One or more sealing rings 226 can beused to seal the central pin 230 to the chamber 205 when in use, toallow an airtight chamber 205. The sealing rings 226 can be, forexample, silicone, or other material, such as in an O-ring shape. Thesealing rings 226 can be, for example, attached to the opening 224 withan adhesive. The sealing rings 226 can, for example, level the centralpin 230 within the assembly 200. The central openings 214, 224, canhave, for example, the sample diameter for fitting the central pin 230.

The actuator 240 can be, for example, an actuator located below thebottom portion 210. The actuator 240 can be, for example, for lifting upand separating the top portion 220 from the bottom portion 210. In someexamples, the actuator 240 can actuate the central pin 230 to induceopening of the chamber 205.

The actuator 240 can be, for example, a pneumatic actuator, anelectrical actuator, a mechanical actuator, a hydraulic actuator, acombination thereof, or another type of actuator. The actuator can beinitiated, for example, by an external controller in communication withthe sampling assembly 200 while the sterilization or disinfection cycleis running. The actuator 240 can, for example, be programmed to open fora specific period of time, such as during a particular portion of thesterilization or disinfection cycle. This is discussed in more detailwith reference to FIG. 4 below.

The base 250 can include a mounting platform 252 and handles 254. Thebase 250 can serve as a bottom for the assembly 200. The actuator 240can be, for example, mounted to platform 252 so that the assembly 200 issecured. The handles 254 can allow for easy movement of the samplingassembly 200 into or out of a sterilization or disinfection system.

The assembly 200 can be, for example, inserted into the chamber of asterilization or disinfection system for verification of thatsterilization or disinfection system. In some cases, the assembly 200can be inserted into the chamber of the system to test the atmosphere inthat chamber. When inserted, the assembly 200 can be, for example, in aclosed position (e.g., a first position) such as shown in FIG. 2B. Inthe closed position, the assembly 200 can be airtight to prevententrance of the atmosphere in the sterilization or disinfection chamberor environment into to the assembly 200 until the desired portion of thesterilization or disinfection cycle.

When verification is desired, the actuator 240 can be initiated to openthe assembly 200, separating the top portion 220 from the bottom portion210. While in an open position (e.g., a second position), such as shownin FIG. 2C, the sampling assembly 200 chamber 205 can collect a sampleof the atmosphere in the sterilization or disinfection system, such as amixture of air and atomized or vaporized sterilant or disinfectant. Insome cases, the sampling assembly 200 can capture a portion of theatmosphere. In some cases, the sampling assembly can host one or moreindicators that can react with the atmosphere.

When the desired exposure time is finished, the actuator 240 can beinitiated to close the sampling assembly 200 back to the closed positionof FIG. 2B. When the sterilization or disinfection cycle is complete,the user can remove the sampling assembly 200 from the sterilization ordisinfection system and test the sample to verify the sterilizationprocess. In some cases, the sampling assembly 200 can be left in thesterilization or disinfection system after the sterilization ordisinfection cycle, and the sample can be removed for testing andverification, without removing the entire sampling assembly 200.

FIGS. 3A-3B are perspective views of a sampling assembly 300, forverifying the environment in a sterilizing or disinfecting system, in anadditional example. The components of sampling assembly 300 are similarto the corresponding components of sampling assembly 200, except whereotherwise noted.

Assembly 300 can include, for example, bottom portion 310 with tray 312,central opening 314, sealing grove 316; top portion 320 with centralopening 324, locking pin 325, and fluid flow ports 327, 328, 329;central pin 330; actuator 340 with ports 342, 344; and base 350.Assembly 300 can additionally include indicators 360 in holder 362.

In sampling assembly 300, fluid flow ports 327, 328, 329 are located onthe top portion 320. The fluid flow ports 327, 328, 329, can be, forexample, vent ports, evacuation or purge ports, or vacuum ports. In someexamples, one or more of the ports can be plugged if they are notdesired for that particular sampling session.

For example, if one or more of the ports is adapted for creation of avacuum in the sampling assembly 300, a vacuum can be induced in thesampling assembly 300 before or at the beginning of the sterilization ordisinfection cycle as desired. The chamber 305 can then be vented asneeded to maintain a vacuum.

In some examples, the one or more ports can be an evacuation or purgeport, such that when the sampling assembly 300 is inserted into thesterilization or disinfection chamber, and the chamber is prepared forsterilization or disinfection, the inside of the chamber 305 of thesampling assembly 300 can be purged of other residual gas or air priorto the sterilization process. In some cases, the ports can be used toclean out the sampling assembly 300.

In sampling assembly 300, the actuator 340 has two ports 342, 344. Theports 242, 244, can be, for example, adapted for initiating pneumaticaction of the actuator 340. This can be performed, for example, byinserting fluid through one or more of the ports 342, 344, and as neededdraining the fluid back out, so that the pneumatic actuator 340 can moveto the appropriate heights for opening or closing the sampling assembly300.

In sampling assembly 300, several indicators 360 reside in the holder362 residing in the bottom portion 310 of the chamber 305. Theindicators 360 can be, for example, biological indicators or chemicalindicators.

Biological indicators can, for example, be affected by microorganismsleft in the sterilization chamber. In general, biological indicators canbe measured for a D-value indicating how long it takes to reduce amicroorganism population by 90%, or the time needed to 1-log reductionof microorganisms. Where multiple biological indicators are usedtogether in the sampling assembly 300, all the biological indicators canbe affected by the atmosphere in the sterilization or disinfectionchamber simultaneously. For example, five, ten, twenty, or morebiological indicators can be used simultaneously to allow forstatistical analysis of multiple biological indicators. Biologicalindicators can be analyzed, for example, with ISO Standard Procedures14937, 11135, or similar.

Chemical indicators can indicate whether an amount of a particularchemical, such as a component of a sterilant, is present, and if it ispresent in a threshold concentration. In some cases, chemical indicatorscan indicate a property of chemicals in the sterilization ordisinfection chamber, such as pH. Multiple chemical indicators can beused simultaneously in the sampling assembly 300, so as to allowstatistical analysis.

The indicators can reside, for example, in the holder 362. The holder362 can be cut specifically to fit snugly in the bottom portion 310. Theholder 362 can be removeable from the bottom portion 310, or can beattached to the bottom portion 310, such as by bolts, adhesive, or otherattachment mechanisms. The holder 362 can have generic holds, bars, orshelves to hold indicators. In some cases, the holder 362 can be cutspecifically to hold a particular type and size of indicator. Wheremultiple holes are cut into the holder 362 for holding indicators, theholes can be evenly spaced to allow even exposure of indicators withinthe sampling assembly 300.

In some cases, indicators are not used. Instead, the chamber 305 can beused to capture a portion of the atmosphere, such as the gas andsterilant or disinfectant mixture, inside the chamber of thesterilization or disinfection system. The sampling assembly 300 can, forexample, capture less than 10% or less than 5% volume of thesterilization or disinfection chamber. In this case, the chamber 305could be resealed around the gaseous sample, and after the sterilizationcycle has concluded, the sampling assembly 300 could be removed and thegaseous sample tested.

For larger sterilization or disinfection chambers or environments, morethan one sampling assembly could be used in the same sterilization ordisinfection chamber, such as, at various portions of the floor of thesterilization or disinfection chamber, evenly spaced or not evenlyspaced. In some cases, the sampling assemblies could be mounted to oneor more walls of the sterilization or disinfection chamber.

FIG. 4 is a graphical illustration of an example cycle 400 in asterilizing or disinfecting system. The cycle 400 includes an evacuationphase 410, an injection phase 420, a hold time 430, a post-injectionevacuation phase 440, and a ventilation phase 450.

In the evacuation phase 410, the sampling assembly can be located in thesterilization or disinfection chamber, and the sterilization ordisinfection chamber can optionally be sealed. Subsequently, thesterilization or disinfection chamber can optionally be vacuumed (e.g.,evacuated) to create the desired pressure inside the sterilization ordisinfection chamber.

In the injection phase 420, one or more sterilants and/or disinfectantscan be injected into the sterilization or disinfection chamber. In somecases, the sterilant or disinfectant can be atomized or vaporized. Insome cases, the sterilant or disinfectant can be directly injected intothe chamber, or can be pumped from a separate channel.

In the hold time 430, the pressure and amount of sterilant ordisinfectant can be held steady to allow for sterilization ordisinfection. During the hold time 430, the sampling assembly can be,for example, opened to expose indicators to the atmosphere in thechamber. The sampling assembly can be again closed by the end of thehold time 430. In other cases, the sampling assembly can be openedduring different phases of the sterilization or disinfection cycle.

In the post-injection evacuation phase 440, the chamber can again bevented or evacuated to manipulate the pressure in the chamber. In theventilation phase 450, the chamber can be vented.

FIG. 5 is a block diagram depicting a method 500 of using a samplingassembly for verifying the environment in a sterilizing or disinfectingsystem. In method 500, a user can situate a sampling assembly in asterilizing or disinfecting system, run the sterilization ordisinfection cycle, open the sampling assembly during a portion of thesterilization or disinfection cycle, and collect a sample in thesampling assembly, followed by analysis of that sample.

The sampling assembly can be, for example, the assembly 200 or 300discussed above. The sampling assembly can be set inside thesterilization or disinfection chamber (operation 510), or attached tothe chamber, such as by bolts, adhesive, or other attachment mechanisms.In some cases, more than one sampling assembly can be used in the samplecycle. The sampling assembly can be, for example, closed and sealed sothat it is airtight prior to the sterilization cycle.

In operation 520, the sterilization or disinfection cycle can be run.The cycle can, for example, include an evacuation phase wherein thechamber is vacuumed, an injection phase where a sterilant and/ordisinfectant is injected into the chamber, a hold phase where thepressure is held, a post-injection evacuation phase where the chamber isvacuumed, and a validation phase.

The sampling assembly can be opened during the sterilization ordisinfection cycle (operation 530). The sampling assembly can be closedlater in the sterilization or disinfection cycle, such that a sample iscollected while the sampling assembly is open and exposed to theatmosphere of the sterilization or disinfection chamber (operation 540).In some cases, the sampling assembly can be opened at the beginning ofthe hold phase and closed at the end of the hold phase. In some cases,the sampling assembly can be opened at closed during one or more of thecycle phases.

The sampling assembly can include, for example, one or more biologicalindicators, one or more chemical indicators, or can be used to capture aportion of the atmosphere inside the sterilization or disinfectionchamber. The sample can then be analyzed to validate the sterilizationor disinfection cycle (operation 550).

Various Notes & Examples

Each of these non-limiting examples can stand on its own, or can becombined in various permutations or combinations with one or more of theother examples.

Example 1 can include a device for use in a disinfection process, thedevice comprising: a sampling assembly capable of a first position and asecond position, wherein the sampling assembly is configured to be usedinside a disinfection system, the sampling assembly comprising: a topportion; a bottom portion; at least one seal therebetween such that thetop portion and the bottom portion form an airtight compartment when inthe first position; a central pin running through the top portion andbottom portion; and an actuator configured to move the sampling assemblybetween the first position and the second position along the central pinduring a portion of the sterilization process, such that the samplingassembly can collect a sample of atmosphere within the sterilizationsystem.

Example 2 can include Example 1, further comprising a base, wherein thesampling assembly is mounted to the base.

Example 3 can include any of Examples 1-2, further comprising a quickrelease pin in the top portion of the sampling assembly, the quickrelease pin configured to prevent movement between the first positionand the second position.

Example 4 can include any of Examples 1-3, wherein the actuatorcomprises a pneumatic actuator, a hydraulic actuator, an electricalactuator, or a mechanical actuator.

Example 5 can include any of Examples 1-4, wherein the sampling assemblyfurther comprises a first fluid flow port for venting the airtightcompartment of the sampling assembly.

Example 6 can include any of Examples 1-5, wherein the sampling assemblyfurther comprises a second fluid flow port for evacuating the airtightcompartment of the sampling assembly.

Example 7 can include any of Examples 1-6, wherein the at least one sealcomprises a first seal between the bottom portion and the top portion,the first seal being around an outer diameter of the bottom portion.

Example 8 can include any of Examples 1-7, wherein the top portion andthe bottom portion each comprise a central hole through which thecentral pin extends.

Example 9 can include any of Examples 1-8, further comprising a secondseal between the bottom portion and the top portion, the second sealaround a diameter of the central hole around the central pin.

Example 10 can include any of Examples 1-9, wherein the central pincomprises a first ridge configured to hold the top portion up whenmoving the sampling assembly from the first position to the secondposition.

Example 11 can include any of Examples 1-10, further comprising asection for holding a specimen or other item under study within theairtight compartment.

Example 12 can include any of Examples 1-11, further comprising a rackfor holding chemical or biological indicators in the bottom portion.

Example 13 can include any of Examples 1-12, further comprising thedisinfection system, wherein the sampling assembly resides in a chamberof the disinfection system.

Example 14 can include a method of validating a disinfecting system,comprising: situating a sampling assembly in a chamber of thedisinfecting system, the sampling assembly comprising: a top portion; abottom portion; and at least one seal therebetween such that the topportion and the bottom portion form an airtight compartment; running adisinfection cycle on the disinfecting system; opening the samplingassembly during a portion of the disinfection cycle; collecting a samplein the sampling assembly; and analyzing the sample.

Example 15 can include Example 14, wherein the disinfection cyclecomprises: an evacuation phase where the chamber is conditioned; aninjection phase where a disinfectant is injected into the chamber; ahold phase where the pressure in the chamber is held; a post-injectionevacuation phase where the chamber is vacuumed; and a validation phase.

Example 16 can include any of Examples 14-15, wherein opening thesampling assembly is performed during the hold phase.

Example 17 can include any of Examples 14-16, further comprising closingthe sampling assembly during the hold phase.

Example 18 can include any of Examples 14-17, wherein collecting asample comprises exposing one or more biological indicators situated inthe sampling assembly to the chamber.

Example 19 can include any of Examples 14-18, wherein collecting asample comprises exposing one or more chemical indicators situated inthe sampling assembly to the chamber.

Example 20 can include any of Examples 14-19, wherein collecting asample comprises taking in a portion of atmosphere of the chamber intothe sampling assembly.

Each of these non-limiting examples can stand on its own, or can becombined in various permutations or combinations with one or more of theother examples.

The above detailed description includes references to the accompanyingdrawings, which form a part of the detailed description. The drawingsshow, by way of illustration, specific embodiments in which theinvention can be practiced. These embodiments are also referred toherein as “examples.” Such examples can include elements in addition tothose shown or described. However, the present inventors alsocontemplate examples in which only those elements shown or described areprovided. Moreover, the present inventors also contemplate examplesusing any combination or permutation of those elements shown ordescribed (or one or more aspects thereof), either with respect to aparticular example (or one or more aspects thereof), or with respect toother examples (or one or more aspects thereof) shown or describedherein.

In the event of inconsistent usages between this document and anydocuments so incorporated by reference, the usage in this documentcontrols.

In this document, the terms “a” or “an” are used, as is common in patentdocuments, to include one or more than one, independent of any otherinstances or usages of “at least one” or “one or more.” In thisdocument, the term “or” is used to refer to a nonexclusive or, such that“A or B” includes “A but not B,” “B but not A,” and “A and B,” unlessotherwise indicated. In this document, the terms “including” and “inwhich” are used as the plain-English equivalents of the respective terms“comprising” and “wherein.” Also, in the following claims, the terms“including” and “comprising” are open-ended, that is, a system, device,article, composition, formulation, or process that includes elements inaddition to those listed after such a term in a claim are still deemedto fall within the scope of that claim. Moreover, in the followingclaims, the terms “first,” “second,” and “third,” etc. are used merelyas labels, and are not intended to impose numerical requirements ontheir objects.

Method examples described herein can be machine or computer-implementedat least in part. Some examples can include a computer-readable mediumor machine-readable medium encoded with instructions operable toconfigure an electronic device (including processing circuitry withinsuch electronic device) to perform methods as described in the aboveexamples. An implementation of such methods can include code, such asmicrocode, assembly language code, a higher-level language code, or thelike. Such code can include computer readable instructions forperforming various methods. The code may form portions of computerprogram products. Further, in an example, the code can be tangiblystored on one or more volatile, non-transitory, or non-volatile tangiblecomputer-readable media, such as during execution or at other times.Examples of these tangible computer-readable media can include, but arenot limited to, hard disks, removable magnetic disks, removable opticaldisks (e.g., compact disks and digital video disks), magnetic cassettes,memory cards or sticks, random access memories (RAMs), read onlymemories (ROMs), and the like.

The above description is intended to be illustrative, and notrestrictive. For example, the above-described examples (or one or moreaspects thereof) may be used in combination with each other. Otherembodiments can be used, such as by one of ordinary skill in the artupon reviewing the above description. The following claims are herebyincorporated into the Detailed Description as examples or embodiments,with each claim standing on its own as a separate embodiment, and it iscontemplated that such embodiments can be combined with each other invarious combinations or permutations.

What is claimed is:
 1. A device for use in a disinfection process, thedevice comprising: a sampling assembly capable of a first position and asecond position, wherein the sampling assembly is configured to be usedinside a disinfection system, the sampling assembly comprising: a topportion; a bottom portion; at least one seal therebetween such that thetop portion and the bottom portion form an airtight compartment when inthe first position; a central pin running through the top portion andbottom portion; and an actuator configured to move the sampling assemblybetween the first position and the second position along the central pinduring a portion of the sterilization process, such that the samplingassembly can collect a sample of atmosphere within the sterilizationsystem.
 2. The device of claim 1, further comprising a base, wherein thesampling assembly is mounted to the base.
 3. The device of claim 1,further comprising a quick release pin in the top portion of thesampling assembly, the quick release pin configured to prevent movementbetween the first position and the second position.
 4. The device ofclaim 1, wherein the actuator comprises a pneumatic actuator, ahydraulic actuator, an electrical actuator, or a mechanical actuator. 5.The device of claim 1, wherein the sampling assembly further comprises afirst fluid flow port for venting the airtight compartment of thesampling assembly.
 6. The device of claim 5, wherein the samplingassembly further comprises a second fluid flow port for evacuating theairtight compartment of the sampling assembly.
 7. The device of claim 1,wherein the at least one seal comprises a first seal between the bottomportion and the top portion, the first seal being around an outerdiameter of the bottom portion.
 8. The device of claim 1, wherein thetop portion and the bottom portion each comprise a central hole throughwhich the central pin extends.
 9. The device of claim 8, furthercomprising a second seal between the bottom portion and the top portion,the second seal around a diameter of the central hole around the centralpin.
 10. The device of claim 1, wherein the central pin comprises afirst ridge configured to hold the top portion up when moving thesampling assembly from the first position to the second position. 11.The device of claim 1, further comprising a section for holding aspecimen or other item under study within the airtight compartment. 12.The device of claim 1, further comprising a rack for holding chemical orbiological indicators in the bottom portion.
 13. The device of claim 1,further comprising the disinfection system, wherein the samplingassembly resides in a chamber of the disinfection system.
 14. A methodof validating a disinfecting system, comprising: situating a samplingassembly in a chamber of the disinfecting system, the sampling assemblycomprising: a top portion; a bottom portion; and at least one sealtherebetween such that the top portion and the bottom portion form anairtight compartment; running a disinfection cycle on the disinfectingsystem; opening the sampling assembly during a portion of thedisinfection cycle; collecting a sample in the sampling assembly; andanalyzing the sample.
 15. The method of claim 14, wherein thedisinfection cycle comprises: an evacuation phase where the chamber isconditioned; an injection phase where a disinfectant is injected intothe chamber; a hold phase where one or more process variables in thechamber is held; a post-injection evacuation phase where the chamber isvacuumed; and a validation phase.
 16. The method of claim 15, whereinopening the sampling assembly is performed at the during the hold phase.17. The method of claim 16, further comprising closing the samplingassembly during the hold phase.
 18. The method of claim 14, whereincollecting a sample comprises exposing one or more biological indicatorssituated in the sampling assembly to the chamber.
 19. The method ofclaim 14, wherein collecting a sample comprises exposing one or morechemical indicators situated in the sampling assembly to the chamber.20. The method of claim 14, wherein collecting a sample comprises takingin a portion of atmosphere of the chamber into the sampling assembly.